Kalorama reports several new OTC categories under consideration by FDA

By Michael Johnsen

NEW YORK — Kalorama Information on Thursday reported that a number of Rx-to-OTC switch applications currently are under review by the Food and Drug Administration across several new-to-self-care categories, including overactive bladder, bacterial infections, cholesterol and high blood pressure.

“We are beginning to see the early preparations for a boost to the OTC market with revived FDA attention to Rx-to-OTC switches,” stated Melissa Elder, analyst for Kalorama Information. “Keep an eye on companies like Merck — known for attempting to provide first-in-category switches.”

Kalorama Information estimates the market for such OTC approaches to be $78 billion in 2011. "Growth has been sluggish in the past few years, but consumer demand and favorable regulation will drive growth in the market as controlling healthcare costs has become a primary concern in recent years," the firm stated.

Earlier this week, DSN reported that the FDA's advisory committee will be meeting to determine whether the overactive bladder medication Oxytrol is appropriate as a nonprescription therapy. For that story, click here.